Staff Perspective: MDMA-Assisted Psychotherapy for PTSD - Reactions from a Skeptic
It’s tough to keep up with the “latest and greatest” interventions for Post-Traumatic Stress Disorder (PTSD). It seems like there’s constantly a new “breakthrough” that never fully delivers. As a scientist-practitioner, I don’t pay much attention until I see a strong research base. So until recently, I’ve all but ignored claims that psychedelic drugs (MDMA, psilocybin, etc.) could bolster recovery from PTSD. However, it’s tough to ignore the successes reported in a recent Phase 3 trial. (Mitchell et al, 2021; Servick, 2021).
Another reason for my skepticism: I grew up in the '80s, fully immersed in the war against drugs. I know from Saturday morning commercials that drugs would scramble my brain like eggs in a frying pan. Nancy Regan instructed me and Arnold Jackson to “just say no.” And a police officer from D.A.R.E. (Drug Abuse Resistance Education) visited my elementary school classroom and warned us that one dose of LSD would give you flashbacks for life. Call me a prude, but I feared psychedelics until….well, today.
Phase 3 clinical trials are often the final step before a medication receives FDA approval. In the recently published Phase 3 study on MDMA for PTSD (Mitchell et al, 2021), 91 participants were randomized to receive a manualized psychotherapy combined with either MDMA or a placebo medication. At the end of the treatment, 67% of the participants who received MDMA no longer met criteria for PTSD, compared to 32% of those who received the placebo. The authors posit that MDMA facilitates trauma recovery by reducing anxiety, increasing self-compassion and social connection, and promoting fear extinction learning. Taken together, “MDMA, when combined with therapy, may produce a ‘window of tolerance’ ” that enables participants to engage in trauma processing with less distress and experience new learning while feeling safe.
This summary inspired me to learn more. After reading the Multidisciplinary Association for Psychedelic Studies’ (MAPS) protocol (MAPS, 2020) for MDMA-assisted therapy for PTSD and discussing it with respected colleagues, I aimed to look at this treatment innovation from a balanced perspective. You know, how I encourage my clients to approach new experiences. Here are my reactions as a self-identified skeptic:
- A core component of this treatment model is trauma processing, which is in line with our gold standard evidence-based psychotherapies for PTSD (i.e., CPT, EMDR, and PE). The researchers conceptualize that healing from trauma involves approaching painful memories and emotions, rather than avoiding them. The psychotherapy portion of treatment utilizes directive and non-directive techniques to facilitate trauma processing. In my mind, the model is not theoretically different from those trauma-focused treatments that I utilize.
- As a clinician (not a physician or neuropsychologist), the rationale behind MDMA’s effectiveness makes sense to me overall. If MDMA truly facilitates extinction learning while the client experiences emotions incompatible with anxiety and fear (i.e., compassion and calm), it could be a powerful tool for trauma recovery. Approaching trauma memories and emotions is hard work. Anything that empowers clients to do the work safely should be applauded.
- The MAPS protocol is time- and resource-intensive. It calls for three “experimental sessions” which last eight hours each + an overnight stay. Nine total “integrative sessions” are also delivered, each of which lasts 90 minutes. Two therapists are present for each of the sessions and a trained “attendant” monitors the patient during overnight stays. The protocol also includes a physician on standby during experimental sessions and follow-up phone calls by a study therapist every other day for two weeks after each experimental session. As written, this protocol will likely only be available to research participants or patients in hospitals/clinics that can provide such intensive treatment and the funding to support it. The average clinician would struggle to deliver this treatment, especially if they work within insurance networks. I worry that most patients would have difficulty accessing this treatment, particularly those whom are already underserved due to socioeconomic factors.
- The MAPS protocol calls for “bodywork” with the explicit permission of the patient. The role of touch in psychotherapy has always been tricky for me. I’m a hugger in my personal life, but am very careful about touching clients, especially those with a history of physical or sexual abuse. I appreciate the explicitness with which physical touch is handled in this protocol, but admit I’d be anxious about it myself. I worry that physical touch can be easily misconstrued by a vulnerable patient.
- Because many antidepressants (SSRIs, SNRIs, and MAOIs) act on similar pathways as MDMA, patients must discontinue use of these medications prior to the first experimental session. The required medication taper makes good sense in ensuring the safety of participants receiving MDMA. However, this requirement does pose an obstacle for patients who are on SSRI-class medications and their providers. Extra care and attention should be provided to patients as they discontinue medications, adding to the time and resources needed to deliver this treatment.
- The MAPS protocol explicitly considers the physical comfort of the patient throughout. This includes consideration of décor (including fresh flowers and artwork), comfortable furnishings, provision of music and eyeshades, and even the availability of snacks. Obviously some of these considerations are specific to the length of the sessions and effects of MDMA. Nonetheless, I appreciate the researchers’ attention to these details, which transcends anything I’ve seen written elsewhere. Although I am thoughtful in the design and ambiance of my office, this protocol inspires me to consistently reevaluate how it is experienced by my patients.
- The study included only participants with severe PTSD. Therefore, the treatment’s generalizability to patients with mild or moderate PTSD is unknown at this time.
- My own biases regarding psychedelics led me to assume that this treatment approach would be unsafe. Of course the researchers addressed safety concerns thoroughly and monitored patients closely during and after MDMA sessions. The most surprising finding to me was that there were two serious adverse events in the placebo group, but none in the experimental group. Additionally, there were more adverse events of special interest in the placebo group than in the experimental group, suggesting that MDMA-assisted psychotherapy does not carry greater risk than placebo.
After taking a deep dive into the research, I am more open to and curious about psychedelic-assisted psychotherapies for PTSD. The Phase 3 study provides initial data regarding the safety and effectiveness of this treatment, though not enough to replace the evidence-based psychotherapies that have decades’ worth of data to support them and that can be delivered safely within many clinical settings. In addition, the treatment as described in the recent study is not easily accessible to most patients. Nonetheless, it appears to be a valuable addition to our existing toolbox, particularly for patients with severe PTSD who have not responded to frontline treatments. So while I’ll continue to practice treatments like CPT and PE, I’m eager to see what findings emerge as this research continues and keep my fingers crossed that we’ll soon have another good option for our patients.
The opinions in CDP Staff Perspective blogs are solely those of the author and do not necessarily reflect the opinion of the Uniformed Services University of the Health Science or the Department of Defense.
Carin Lefkowitz, Psy.D., is a clinical psychologist and Senior Military Behavioral Health Psychologist at the Center for Deployment Psychology (CDP) at the Uniformed Services University of the Health Sciences in Bethesda, Maryland.
REFERENCES
Multidisciplinary Association for Psychedelic Studies (2020, May 22). A randomized, double-blind, placebo-controlled, multi-site phase 3 study of the efficacy and safety of manualized MDMA-Assisted psychotherapy for the treatment of severe posttraumatic stress disorder. Retrieved from https://maps.org/research/mdma/ptsd/phase3
Mitchell, J., Bogenschutz, M., Lilienstein, A., Harrison, C., Kleiman, S., Parker-Guilbert, K., Ot’alora, M., Garas, W., Paleos, C., Gorman, I., Nicholas, C., Mithoefer, M., Carlin, S., Poulter, B., Mithoefer, A., Quevedo, S., Wells, G., Klaire, S., van der Kolk, B., … & Doblin, R. (2021). MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine. https://doi.org/10.1038/s41591-021-01336-3
Servick, K. (2021). A psychedelic win raises questions for PTSD therapy. Science, 372(6544), 774-775.
It’s tough to keep up with the “latest and greatest” interventions for Post-Traumatic Stress Disorder (PTSD). It seems like there’s constantly a new “breakthrough” that never fully delivers. As a scientist-practitioner, I don’t pay much attention until I see a strong research base. So until recently, I’ve all but ignored claims that psychedelic drugs (MDMA, psilocybin, etc.) could bolster recovery from PTSD. However, it’s tough to ignore the successes reported in a recent Phase 3 trial. (Mitchell et al, 2021; Servick, 2021).
Another reason for my skepticism: I grew up in the '80s, fully immersed in the war against drugs. I know from Saturday morning commercials that drugs would scramble my brain like eggs in a frying pan. Nancy Regan instructed me and Arnold Jackson to “just say no.” And a police officer from D.A.R.E. (Drug Abuse Resistance Education) visited my elementary school classroom and warned us that one dose of LSD would give you flashbacks for life. Call me a prude, but I feared psychedelics until….well, today.
Phase 3 clinical trials are often the final step before a medication receives FDA approval. In the recently published Phase 3 study on MDMA for PTSD (Mitchell et al, 2021), 91 participants were randomized to receive a manualized psychotherapy combined with either MDMA or a placebo medication. At the end of the treatment, 67% of the participants who received MDMA no longer met criteria for PTSD, compared to 32% of those who received the placebo. The authors posit that MDMA facilitates trauma recovery by reducing anxiety, increasing self-compassion and social connection, and promoting fear extinction learning. Taken together, “MDMA, when combined with therapy, may produce a ‘window of tolerance’ ” that enables participants to engage in trauma processing with less distress and experience new learning while feeling safe.
This summary inspired me to learn more. After reading the Multidisciplinary Association for Psychedelic Studies’ (MAPS) protocol (MAPS, 2020) for MDMA-assisted therapy for PTSD and discussing it with respected colleagues, I aimed to look at this treatment innovation from a balanced perspective. You know, how I encourage my clients to approach new experiences. Here are my reactions as a self-identified skeptic:
- A core component of this treatment model is trauma processing, which is in line with our gold standard evidence-based psychotherapies for PTSD (i.e., CPT, EMDR, and PE). The researchers conceptualize that healing from trauma involves approaching painful memories and emotions, rather than avoiding them. The psychotherapy portion of treatment utilizes directive and non-directive techniques to facilitate trauma processing. In my mind, the model is not theoretically different from those trauma-focused treatments that I utilize.
- As a clinician (not a physician or neuropsychologist), the rationale behind MDMA’s effectiveness makes sense to me overall. If MDMA truly facilitates extinction learning while the client experiences emotions incompatible with anxiety and fear (i.e., compassion and calm), it could be a powerful tool for trauma recovery. Approaching trauma memories and emotions is hard work. Anything that empowers clients to do the work safely should be applauded.
- The MAPS protocol is time- and resource-intensive. It calls for three “experimental sessions” which last eight hours each + an overnight stay. Nine total “integrative sessions” are also delivered, each of which lasts 90 minutes. Two therapists are present for each of the sessions and a trained “attendant” monitors the patient during overnight stays. The protocol also includes a physician on standby during experimental sessions and follow-up phone calls by a study therapist every other day for two weeks after each experimental session. As written, this protocol will likely only be available to research participants or patients in hospitals/clinics that can provide such intensive treatment and the funding to support it. The average clinician would struggle to deliver this treatment, especially if they work within insurance networks. I worry that most patients would have difficulty accessing this treatment, particularly those whom are already underserved due to socioeconomic factors.
- The MAPS protocol calls for “bodywork” with the explicit permission of the patient. The role of touch in psychotherapy has always been tricky for me. I’m a hugger in my personal life, but am very careful about touching clients, especially those with a history of physical or sexual abuse. I appreciate the explicitness with which physical touch is handled in this protocol, but admit I’d be anxious about it myself. I worry that physical touch can be easily misconstrued by a vulnerable patient.
- Because many antidepressants (SSRIs, SNRIs, and MAOIs) act on similar pathways as MDMA, patients must discontinue use of these medications prior to the first experimental session. The required medication taper makes good sense in ensuring the safety of participants receiving MDMA. However, this requirement does pose an obstacle for patients who are on SSRI-class medications and their providers. Extra care and attention should be provided to patients as they discontinue medications, adding to the time and resources needed to deliver this treatment.
- The MAPS protocol explicitly considers the physical comfort of the patient throughout. This includes consideration of décor (including fresh flowers and artwork), comfortable furnishings, provision of music and eyeshades, and even the availability of snacks. Obviously some of these considerations are specific to the length of the sessions and effects of MDMA. Nonetheless, I appreciate the researchers’ attention to these details, which transcends anything I’ve seen written elsewhere. Although I am thoughtful in the design and ambiance of my office, this protocol inspires me to consistently reevaluate how it is experienced by my patients.
- The study included only participants with severe PTSD. Therefore, the treatment’s generalizability to patients with mild or moderate PTSD is unknown at this time.
- My own biases regarding psychedelics led me to assume that this treatment approach would be unsafe. Of course the researchers addressed safety concerns thoroughly and monitored patients closely during and after MDMA sessions. The most surprising finding to me was that there were two serious adverse events in the placebo group, but none in the experimental group. Additionally, there were more adverse events of special interest in the placebo group than in the experimental group, suggesting that MDMA-assisted psychotherapy does not carry greater risk than placebo.
After taking a deep dive into the research, I am more open to and curious about psychedelic-assisted psychotherapies for PTSD. The Phase 3 study provides initial data regarding the safety and effectiveness of this treatment, though not enough to replace the evidence-based psychotherapies that have decades’ worth of data to support them and that can be delivered safely within many clinical settings. In addition, the treatment as described in the recent study is not easily accessible to most patients. Nonetheless, it appears to be a valuable addition to our existing toolbox, particularly for patients with severe PTSD who have not responded to frontline treatments. So while I’ll continue to practice treatments like CPT and PE, I’m eager to see what findings emerge as this research continues and keep my fingers crossed that we’ll soon have another good option for our patients.
The opinions in CDP Staff Perspective blogs are solely those of the author and do not necessarily reflect the opinion of the Uniformed Services University of the Health Science or the Department of Defense.
Carin Lefkowitz, Psy.D., is a clinical psychologist and Senior Military Behavioral Health Psychologist at the Center for Deployment Psychology (CDP) at the Uniformed Services University of the Health Sciences in Bethesda, Maryland.
REFERENCES
Multidisciplinary Association for Psychedelic Studies (2020, May 22). A randomized, double-blind, placebo-controlled, multi-site phase 3 study of the efficacy and safety of manualized MDMA-Assisted psychotherapy for the treatment of severe posttraumatic stress disorder. Retrieved from https://maps.org/research/mdma/ptsd/phase3
Mitchell, J., Bogenschutz, M., Lilienstein, A., Harrison, C., Kleiman, S., Parker-Guilbert, K., Ot’alora, M., Garas, W., Paleos, C., Gorman, I., Nicholas, C., Mithoefer, M., Carlin, S., Poulter, B., Mithoefer, A., Quevedo, S., Wells, G., Klaire, S., van der Kolk, B., … & Doblin, R. (2021). MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine. https://doi.org/10.1038/s41591-021-01336-3
Servick, K. (2021). A psychedelic win raises questions for PTSD therapy. Science, 372(6544), 774-775.